Amino acid and Carnitine Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)
by Bgi Europe a/S Denmark EUDAMED
Ref MFG030024; MFG030025Model 96, 960T
EMDN W01010499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05744003510061 | Date26 May 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Amino acid and Carnitine Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)
- Model / Reference
- 96, 960T, MFG030024, MFG030025
- Primary DI / UDI-DI
- 05744003510061
- Basic UDI-DI
- B-05744003510061
- EMDN Code
- W01010499 Multiple clin. chem lab reagents - other
- Device Class
- Class IVD General
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- DK-MF-000014089
Other devices from Bgi Europe a/S
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED f401ab7b-c11f-44ef-a003-82e5a15958ef-1